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临床试验/NCT04436302
NCT04436302Unknown不适用

The Efficacy of Exergaming in People With Major Neurocognitive Disorder Residing in Long-term Care Facilities: A Randomized Controlled Trial

Davy Vancampfort1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
NPI

研究概览

简要总结

This randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (MNCD) residing in long-term care facilities.

详细描述

This randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (MNCD) residing in long-term care facilities. Fifty inpatients with mild to moderate MNCD will be randomly assigned to three times weekly for eight weeks 15 min of exergaming versus watching preferred music videos. The Montréal Cognitive Assessment (MoCA), Short Physical Performance Battery (SPPB), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Dementia Quality of Life (DQoL), Katz activities of daily living (ADL) and Instrumental ADL (IADL) are measured at baseline and post intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •a Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 diagnosis of MNCD (American Psychiatric Association, 2013)
  • •aged 65 years or older
  • •a score of minimum 10 on the Mini-Mental State Examination (MMSE)
  • •residing at least two weeks in the care facility at the time of inclusion
  • •being physically capable of doing standing exercises (whether or not with extra support).
  • •Possible causes of MNCD were vascular dementia, Alzheimer's disease, mixed dementia, Parkinson's disease or Lewy body disease.

排除标准

  • •consisted of:
  • •any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation
  • •a score lower than 10 on the MMSE
  • •a planned transfer to another setting within the following two months.

研究组 & 干预措施

Intervention

Experimental

Dividat senso exergame device

干预措施: Exergame device (Device)

Control

Active Comparator

Listening to music

干预措施: Exergame device (Device)

结局指标

主要结局

NPI

时间窗: 2 years

Neuropsychiatric Inventory

(I)ADL

时间窗: 2 years

Activities of daily living

MoCA

时间窗: 2 years

Montréal Cognitive Assessment

SPPB

时间窗: 2 years

Short Physical Performance Battery

CSDD

时间窗: 2 years

Cornell Scale for Depression in Dementia

DQOL

时间窗: 2 years

Dementia Quality of Life

次要结局

未报告次要终点

研究者

发起方
Davy Vancampfort
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Davy Vancampfort

Professor

KU Leuven

研究点 (1)

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